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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. G6 SENSOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 5282138
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Irritation (1941); Itching Sensation (1943); Scarring (2061); Reaction (2414)
Event Date 10/28/2020
Event Type  Injury  
Event Description
I've been using dexcom sensors for almost 6 years, but only recently did i start having a severe reaction to the adhesive (around end of october). Due to lack of transparency/communication i thought i was doing something wrong or had developed an allergy. I discussed this with my endocrinologist in december after trying to use the sensors three times, all resulting in red, itchy, bumpy, puffy skin in the exact oval of the sensor. They said that allergies typically develop soon after starting the product initially so she didn't think an allergy was causing the reaction, just a bad batch of sensors. I spoke with dexcom a few times and found out after several calls and complaints that in (b)(6) of 2019 they changed the adhesive without notifying consumers. They let me know that this new sensor adhesive didn't reach many consumers until recently for warehouse/storage reasons. Many of their recommendations indicated that they believed the reaction to be allergy related (although i don't have any other known skin allergies). And when asked to view a list of ingredients (i'm concerned about needing to know what i could be allergic to), they weren't able to disclose that. Months later, the spots where i had applied sensors (the three old sites are in between my lower abdomen and back areas on both my right and left sides) still itch at times. So i have phantom itchiness and dark oval scarring from the sensors. The skin is sort of dry in those areas and even though i've been applying cortisone cream, it's still irritated at times, especially after a warm shower. I believe on all three sites where i had direct skin contact with the sensors, i couldn't wear them the full 10 days. After two days the itchiness began. The first sensor in october also didn't irritate my skin quite as bad as the two after. Fda safety report id # (b)(4).
 
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Brand NameG6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11285583
MDR Text Key230730549
Report NumberMW5099242
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/03/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number5282138
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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